Improving Varenicline Adherence and Outcomes in Homeless Smokers

University of Minnesota (UMN)

Status and phase: Completed; Phase 3

Conditions: Tobacco Use Cessation

Treatments: Other: Varenicline plus Motivational Interviewing counseling; Other: Varenicline without counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT00786149

0708M14444

HL081522

NIH-522

Details and patient eligibility

About

the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.

Full description

Despite significant declines in cigarette smoking rates among adults in the United States in the last few decades, smoking rates remain high among poor and underserved populations. One underserved group is the 4 million homeless persons in the US among whom cigarette smoking rate is an alarming 70% or more; these rates are 3 times higher than national average. Two of the three leading causes of death among homeless persons, heart disease and cancer are tobacco related.2, 3 Despite very high smoking prevalence and disease burden in this population smoking cessation research have not been extended to the homeless. Recent studies including data from our research team show a considerable degree of readiness to quit smoking by homeless smokers and that nicotine replacement therapy (NRT) plus counseling show promise. However, homeless persons face many challenges that may constitute barriers for them to adhere to smoking cessation treatments even if such treatments have been proven effective in the general population. In order to reduce smoking-related health disparities within this underserved population, it is critical that cessation interventions including strategies to improve treatment adherence be developed to include homeless smokers. The primary aim of this study is to assess the effects of adherence-focused motivational interviewing (MI) to help homeless persons quit smoking.

Recruitment and retention will be enhanced by use of bus passes for transportation, debit cards, attractive intervention materials, collaboration with homeless shelters, and advice from a community advisory board. If successful, this study will provide a model for how to overcome barriers to cancer prevention services among homeless persons. It will also provide the impetus for policy changes directed at increasing homeless persons' access to smoking cessation pharmacotherapy and treatment.

Enrollment: 428 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• currently homeless
• smoke 5 or more cigarettes per day
• smoked 100 cigarettes in lifetime
• aged 18 years or older

Exclusion criteria

• unstable mental illness
• pregnancy
• current history of psychoactive or alcohol dependence or psychotic disorder
• cognitive impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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428 participants in 2 patient groups

1

Experimental group

Description:

Participants will receive NRT and Motivational Interviewing counseling

Treatment:

Other: Varenicline plus Motivational Interviewing counseling

2

Active Comparator group

Description:

Varenicline plus brief advice

Treatment:

Other: Varenicline without counseling